Breast Cancer, CIPN - Chemotherapy-Induced Peripheral Neuropathy, Paclitaxel-induced Peripheral Neuropathy
Conditions
Keywords
Breast Cancer, paclitaxel-Induced Peripheral Neuropathy, Hyperbaric Oxygen Therapy
Brief summary
The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.
Interventions
Patients who meet the inclusion criteria will be enrolled and given hyperbaric oxygen intervention, one per day for 90-120 minutes, for a total of 20-30 hyperbaric oxygen treatments (100% oxygen at a pressure of 2.0 ATA)
OTHERStandard Care (in control arm)
Standard care
Sponsors
Guangdong Provincial People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Intervention group: In this group, patients will receive hyperbaric oxygen therapy at 2 absolute atmosphere, once a day, with each session lasting 90-120 minutes, for a total of 20-30 sessions. Control group: standard care
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. aged ≥ 18 years and ≤ 75 years, female 2. early-stage breast cancer or locally advanced breast cancer 3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel 4. The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4/10. 5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.
Exclusion criteria
1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline. 2. Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology. 3. Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment). 4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction. 5. Karnofsky Performance Status score \< 80 6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-CIPN20 subscales | baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended. | Self-reported neuropathy was assessed with the European Organisation for the Research and Treatment of Cancer Quality of Life (EORTC QLQ) CIPN20, which contains 20 items divided into three subscales assessing sensory, motor and autonomic symptoms. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much'. Scores were transformed to a 0-100 scale, with higher scores representing more complaints |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| NCI-CTCAE 5.0 | baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended | Patients will be assessed by professional physicians in accordance with the CTCAE Version 5.0 grading criteria. The evaluated items include peripheral sensory neuropathy, peripheral motor neuropathy, dysesthesia, paresthesia, myalgia, arthralgia, and neuralgia, each of which will be graded on a scale from Grade 0 to Grade 4 |
| EORTC QLQ-C30 | baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended | QoL was assessed with the EORTC QLQ-C30, which contains five functional scales, a global health status/QoL scale, three symptoms scales and six single items. Each item was scored on a scale ranging from 1 'not at all' to 4 'very much', except for the global QoL scale that ranges from 1 'very poor' to 7 'excellent'. Scores were transformed to a 0-100 scale, where higher scores indicate better functional status and quality of life (QoL), whereas higher scores reflect more severe symptoms. |
| BPI-SF | baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended | Patient-reported pain severity and functional interference was assessed using the well-validated Brief Pain Inventory-Short Form (BPI-SF). The Brief Pain Inventory-Short Form (BPI-SF) includes four items that assess average, worst, least, and current pain severity over the past 24 hours. Each pain severity item is rated on an 11-point numeric rating scale (0 = no pain; 10 = pain as bad as you can imagine). Moreover, seven BPI items-assessing interference with daily activities/functions-are scored using the same 11-point scale (0 = does not interfere; 10 = completely interferes), consistent with established methodology. The seven items were summed to obtain a total interference score. |
| Nerve Conduction Velocity | baseline, after intervention (week 6) and 1 , 3 , 6 and 12month after the intervention ended | Sensory nerve conduction velocity (SNCV) and motor nerve conduction velocity (SNCV) will be measured. The nerves measured included the tibial nerve, sural nerve, median nerve, and ulnar nerve. |
Countries
China
Contacts
CONTACTKun Wang, PhD
CONTACTYingcong Lin, Master of Medicine
PRINCIPAL_INVESTIGATORKun Wang
Guangdong Provincial People's Hospital
Outcome results
None listed